E-liquid and vape device manufacturers are racing to complete a task that will determine whether they’re able to remain in business. And it’s possible that hundreds or even thousands don’t even understand what lies ahead.
The deadline for all e-liquid and device manufacturers to register their establishments and provide a listing of products is Sept. 30.
Many manufacturers have long since completed this task. But there is concern within the vaping industry that many small businesses — especially small vape shops that make e-liquid in house — may not be aware of the looming deadline.
Some business owners misunderstood the recent FDA announcement of a delay to the final PMTA deadline. Some mistakenly believe that all of the deadline dates in the deeming rule have been postponed. That is simply not true.
The deadline was originally slated for Dec. 31, 2016. Just a few weeks before that date, the agency postponed the registration and product listing deadline to June 30, 2017. Then in May, all future deadlines were delayed by 90 days, to “allow new leadership at the FDA and the Department of Health and Human Services additional time to more fully consider issues raised by the final rule.”
On July 28, FDA commissioner Scott Gottlieb made the bombshell announcement that the agency would completely rethink tobacco and nicotine policy, and that the final PMTA deadline would be postponed from Nov. 8, 2018 to Aug. 8, 2022.
The only date change since then is a possible delay for businesses directly impacted by the hurricanes in Texas and Florida. “For entities who need additional time to comply with the September 30 deadline because they were directly impacted by recent natural disasters,” FDA is offering to address each situation on a case-by-case basis.
The consequences of not registering
According to the FDA, manufacturers are all businesses involved in “manufacture, preparation, compounding, or processing.” That includes any facility that repackages, or changes the packaging, container, or labels.
Only vape shops and businesses that manufacture products themselves have to register and provide a listing of products. Shops that only sell products made by other companies do not have to register.
Manufacturers of e-liquid and vaping devices that were on the market before August 8, 2016 who have not registered all of their facilities and listed all of their products with the FDA as of October 1 will be in noncompliance, and will be subject to FDA enforcement actions.
“Failing to register is the equivalent of putting a bright red target on your back,” says American Vaping Association president Gregory Conley. “Even under its new leadership, I have no doubt that the FDA will be enforcing the agency’s ban on new or unregistered products.”
“The FDA can and will order products to be removed from the market, up to and including permanent seizure, and the agency has the power to do much worse in the event of noncompliance.”
The danger goes beyond a few shops being shut down. The FDA would very much like to paint the entire industry as the Wild West by showing that hundreds of businesses refused or couldn’t be bothered to follow the requirements in federal regulations.
“These enforcement actions have negative implications beyond the impact on the individual business owner,” says Conley. “From a larger perspective, negative press generated from these enforcement actions will only further the Center for Tobacco Products’ goal of making the entire e-liquid industry look like a bunch of craven amateurs in desperate need of strict regulation.”
What do manufacturers have to do?
While it may sound simple, the process of registering with the FDA as a “tobacco manufacturer” is troublesome enough that a cottage industry has grown up around it. Some businesses have even hired consultants to offer advice on the procedures .
First, all manufacturers have to register each of their facilities in the FDA’s online system. All of the registration and listing is typically done through the Tobacco Registration and Product Listing Module (TRLM) of the FDA Unified Registration and Listing System (FURLS). (FDA also has an option to fill out paper forms and mail them to the agency — though this would be much more difficult if a manufacturer had more than a few products to list.)
Manufacturers must list each product they manufacture — including a separate line listing for each variation in bottle size, nic strength, PG/VG ratio, and flavor. That doesn’t sound bad — until you consider all the options e-liquid makers offer!
If a company sells 100 flavors, and each one is available in 0, 3, 6, 12, and 18 mg/mL, and each of those is available in 30/70 PG/VG, and 50/50, and 70/30; and they’re all available in 30, 60, and 100 mL bottles, the company has 4,500 separate items to list!
If that sounds time consuming, it is. Many e-liquid makers have spent days, or even weeks, completing their listings. The product listings can be uploaded using a spreadsheet, which speeds up the process, but that has caused some manufacturers headaches too.
The manufacturer has to submit the labels and packaging artwork for each product too. However, procrastinators got a gift from the FDA when it announced last week that manufacturers could submit one label to represent all variations on a single flavor. That means that separate labels for each nicotine strength, PG/VG ratio, and bottle size is no longer necessary.
Is there help available for businesses?
The FDA system, by all accounts, is not a breeze to navigate. The agency has produced a series of webinars to explain all aspects of the tobacco regulation universe to newly deemed “tobacco manufacturers.” Much of the webinar content seems confusing to me — although I’m sure those that deal with the FURLS system regularly get more out of it that I did.
But there are other sources of help available for those who need it. As a rank amateur, I found the easiest-to-understand information came from the vaping trade associations.
Both Smoke-Free Alternatives Trade Association (SFATA) and the Vapor Technology Association (VTA) offer guidance to their members, in written form, and video or audio webinars that can help confused vendors find their way through the FDA maze.
There is no excuse at this point for any manufacturer, big or small, to not be part of one of these groups. Both offer extremely inexpensive membership plans for small businesses. And aside from getting help with a crucial task like registering with the FDA, the trade organizations do much more for their members (and for the vaping world in general).
They provide lobbying in Washington, D.C., legal advise on regulatory issues, help vet and train lobbyists for state organizations, testify at hearings, conduct meetings with legislators, offer media and business training — and best of all, they allow small business people to get advice and guidance from their very successful peers.
Both groups are very focused on helping members successfully navigate the murky regulatory waters of the deeming regulations. SFATA has a closed Facebook group for members that provides help on issues like registration and product listings.
Another Facebook group called Vape Industry Help Group – FDA Reg. & Flavor Submissions gave me permission to mention them here, and encourage vendors to ask to be added (the group is closed, but available to any manufacturer who needs help).
This group is a wonderful combination of large and small vendors, and all participants seem generous and helpful. They cover topics big and small, and seem willing to answer questions from rookies about the most basic issues.
It’s time to get serious about this
There are a lot of vape shops that haven’t been run like real businesses. It’s not an insult. Many vapers were so and excited about the thing that finally — miraculously! — helped them quit smoking that they wanted to help others discover vaping too. So they opened stores, many without having any previous retail or business experience.
Some vape shop owners were business naturals, and some weren’t. Some who weren’t worked hard to learn their new job. Others just let the traffic determine the course of the business. Some even continue to work regular jobs and run their shops too.
Making e-liquid in the store was pretty easy to learn. Shops that make their own have a huge cost advantage over those that buy from other manufacturers. And until recently, there wasn’t much to know about federal regulations for vape shops.
But vaping is now a regulated industry. And businesses that succeed — large or small — will have to learn to navigate the new regulated environment. Some won’t. Some will throw their hands in the air and walk away from the vaping industry.
Those who stay will have to be more savvy than they have been. They’ll have to make understanding regulatory compliance an advantage to them in their local markets. And those that make e-liquid on site will have to start to see themselves the way the FDA does, as tobacco manufacturers.
There’s no point in denying it. This is the hand we’ve been dealt. If you make e-liquid or devices, you have to register — and you’ll have to renew the registration every year. You have to give the FDA a list of everything you make. It’s not optional. It’s time to learn and grow.
You have 11 days to be a carefree e-liquid maker. Then you have to get serious.